Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01337752
First received: April 12, 2011
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

The study will evaluate the effects of BHQ880 in patients with previously untreated multiple myeloma and renal insufficiency who are not considered candidates for bisphosphonate therapy. The primary objective of the study will be to evaluate the effect of BHQ880 in combination with bortezomib and dexamethasone, compared to placebo administered with the combination on the time to first Skeletal Related Event (SRE) on study.


Condition Intervention Phase
Multiple Myeloma
Renal Insufficiency
Drug: BHQ880
Drug: BHQ990
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Randomized Phase 2 Study of BHQ880, an Anti-Dickkopf1 (DKK1) Monoclonal Antibody (mAb), in Patients With Untreated Multiple Myeloma and Renal Insufficiency

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • effect of BHQ880 compared with placebo on time to first Skeletal Related Event (SRE) in patients with untreated multiple myeloma and renal insufficiency in combination with bortezomib and dexamethasone [ Time Frame: 18-month median time to first SRE assumed for the placebo arm ] [ Designated as safety issue: No ]
    Time to first SRE from randomization


Secondary Outcome Measures:
  • safety and tolerability of BHQ880 in combination with bortezomib and dexamethasone [ Time Frame: From screening through month 17 ] [ Designated as safety issue: Yes ]
    Number of patients with adverse events/serious adverse events, abnormal clinical laboratory values, and the assessment of immunogenicity

  • Characterize the PharmacoKinetics (PK) profiles of BHQ880 and bortezomib [ Time Frame: At screening and weeks 1, 2, 4, 7, 10, 11, 13, 16, 25 and 34 ] [ Designated as safety issue: Yes ]
    Determine the pharmacokinetic parameters for BHQ880 and bortezomib (Cmax, Tmax, AUC0-tlast, t1/2, and accumulation ratio of BHQ880).

  • Evaluate the effect of BHQ880 on bone metabolism [ Time Frame: At screening and at months 3, 6, 12, and 18 ] [ Designated as safety issue: No ]
    1) Change in bone mineral density, measured by dual-emission X-ray absorptiometry (DXA), from randomization to 12 and 18 months; 2) Change in bone strength, measured by quantitative computed tomography (qCT), from randomization to 3 and 6 months

  • Determine the antimyeloma effect of BHQ880 compared to placebo when used in combination with bortezomib and dexamethasone. [ Time Frame: From the first dose of study medication through month 17 ] [ Designated as safety issue: No ]
    1) The overall response rate (partial response plus complete response); 2) Progression-free survival following initiation of BHQ880


Enrollment: 9
Study Start Date: January 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BHQ880 Drug: BHQ880
Placebo Comparator: BHQ880 Placebo Drug: BHQ990

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Confirmed diagnosis of multiple myeloma
  2. Life expectancy of more than 6 months in the absence of intervention
  3. Must not have received previous or be receiving current antimyeloma therapies
  4. Renal insufficiency
  5. Recovered from the effects of any prior surgery or radiotherapy

Exclusion Criteria:

  1. Prior IV bisphosphonate therapy at any time or oral bisphosphonate therapy within 4 months of study entry
  2. Paget's disease of bone or uncorrected hyperparathyroidism
  3. Impaired cardiac function
  4. Known HIV, known active hepatitis B, or known or suspected hepatitis C infection
  5. Pregnant or nursing (lactating) women,
  6. Women of child-bearing potential, UNLESS agreeable to using 2 birth control methods

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01337752

Locations
United States, Illinois
University Chicago Hospital Dept. of Univ of Chicago (2)
Chicago, Illinois, United States, 60637
United States, Washington
Medical Oncology Associates, PS
Spokane, Washington, United States, 99208
Spain
Novartis Investigative Site
Valencia, Comunidad Valenciana, Spain, 46026
Novartis Investigative Site
Madrid, Spain, 28006
United Kingdom
Novartis Investigative Site
Bournemouth, United Kingdom, BH7 7DW
Novartis Investigative Site
Manchester, United Kingdom, M13 9WL
Novartis Investigative Site
Oxford, United Kingdom, OX3 7LJ
Novartis Investigative Site
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01337752     History of Changes
Other Study ID Numbers: CBHQ880A2203, 2009-010875-26
Study First Received: April 12, 2011
Last Updated: February 18, 2014
Health Authority: United States: Food and Drug Administration
Brazil: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Korea: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Spanish Agency of Medicines
Thailand: Food and Drug Administration
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
multiple myeloma
renal insufficiency
untreated multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Renal Insufficiency
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014